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dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 ...

FDA Recall #D-0315-2022 — Class II — November 12, 2021

Recall #D-0315-2022 Date: November 12, 2021 Classification: Class II Status: Terminated

Product Description

dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

SterRx, LLC — Plattsburgh, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

8946 bags

Distribution

U.S.A. Nationwide

Code Information

S21200/BVC 15-Nov-21 S21296/BYM 19-Dec-21 S21320/BZG 4-Jan-22 S21164/BTV 3-Dec-21 S21191/BUU 18-Dec-21 S21197/BUZ 31-Dec-21 S21220/BVV 13-Jan-22 S21271/BXO 27-Jan-22 S21272/BXP 28-Jan-22 S21299/BYP 18-Feb-22 S21300/BYQ 19-Feb-22

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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